http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Prescription and OTC Drug Product List 9/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ 4MG BASE N19604...
Prescription and OTC Drug Product List 9/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 9: September 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE - ADD - ARSENIC TRIOXIDE TABLET; ORAL - ADD - INJECTABLE; INJECTION HYDROCODONE BITARTRATE AND ACETAMINOPHEN - ADD - TRISENOX - ADD ...
http://www.fda.gov/cder/foi/appletter/2000/75103ltr.pdf ANDA 75- 103 September 29, 2000 Alpharma, UCodamine Syrup (Hydrocodone Bitartrate ...
http://www.fda.gov/cder/foi/appletter/2000/75103ltr.pdf page 1
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt PETERSBURG, FL" 12840 02-Feb-98 GRUPPO LEPETIT SPA "OXYBUTYNIN CHLORIDE, MANUFACTURED IN GARESSIO,ITALY" 12848 05-Feb-98 JOHNSON MATTHEY INC "HYDROCODONE BITARTRATE, USP MANUFACTURED IN WEST DEPTFORD, NEW JERSEY." 12851 05-Feb-98 PFANSTIEHL LABORATORIES INC "DECITABINE, MANUFACTURED IN WAUKEGAN,IL." 12854 10-Feb-98 YAMANOUCHI PHARMACEUTICAL CO LTD "YM087 DRUG SUBSTANCE,...
Prescription and OTC Drug Product List 9/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- +...
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA +...
Prescription and OTC Drug Product List 1/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML...
Prescription and OTC Drug Product List 2/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 2: February 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CICLOPIROX TABLET; ORAL CREAM; TOPICAL LORTAB LOPROX - DLT - UCB 325MG;5MG N40099 001 - ADD - + AVENTIS PHARMS 0.77% N18748 001 - DLT - JUN 25,...
Prescription and OTC Drug Product List 1/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 1: January 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE ...
PDPL PRESCRIPTION DRUG PRODUCT LIST- 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 8 / JAN'96 - AUG'96 ACETAMINOPHEN; BUTALBITAL ALPRAZOLAM TABLET; ORAL TABLET; ORAL BUTALBITAL AND ACETAMINOPHEN ALPRAZOLAM - DLT - AB HALSEY 325MG;50MG N89568 001 - ADD - AB NOVOPHARM 2MG N74085 004 - DLT - OCT 05, 1988 - ADD - FEB 26, 1996 - ADD - @ 325MG;50MG N89568 001 - ADD - OCT 05,...
FDA Drug Approvals List September 2000 Original Application #: 021251 Approval Date: 15-SEP-00 Trade Name: KALETRA Chemical Type: Therapeutic Potential: Dosage Form: SOLUTION Applicant: ABBOTT LABORATORIES Active Ingredient(s): LOPINAVIR OTC/RX Status: RX Indication(s): For the treatment of HIV-1 infection in adults and pediatric patients age six months and older Original Application #: 021226 Approval Date: 15-SEP-00...
http://www.fda.gov/cder/da/ddpa92.wpd 20 005 CARDENE SR SYNTEX NICARDIPINE HYDROCHLORIDE 01 23 92 (CAPSULE, PALO ALTO, CA 30MG EXTENDED RELEASE) 94304 45MG 60MG (CALCIUM ION INFLUX INHIBITOR) [HYPERTENSION] 73 243* LOPERAMIDE HCL PERRIGO LOPERAMIDE HYDROCHLORIDE 01 21 92 (SOLUTION) ALLEGAN, MI 1MG/5ML 49010 (ANTIDIARRHEAL) (OTC) 81 264 BENZTROPINE MESYLATE MUTUAL PHARM BENZTROPINE MESYLATE 01 23 92 (TABLET)...
ANDAs Approvals - September 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals- September 2000 Page: 1 Friday, October 06, 2000 1HYDROCODONE BITARTRATE MALLINCKRODT, INC
author: USERNAME
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
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DDPA August 1996 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC 01-AUG-96 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL (SUPPL-013) 45285 (NEW INDICATION --...
August Drug Approvals Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1 Therapeutic...
Teva Pharmaceutical Industries - News and PR Jerusalem, Israel and Tokyo, Japan, May 15, 2003 Teva Announces Approval of Moexipril HCl Tablets Jerusalem, Israel, May 8, 2003 Teva Announces Approval of Megestrol Acetate Oral Suspension Jerusalem, Israel, May 6, 2003 Teva Announces Settlement of Litigation with GSK on Nabumetone Jerusalem, Israel, April 30, 2003 Teva to Report First Quarter 2003 Financial Results on May 1, 2003...
Microsoft Word - NewYork_2683824_9.DOC FORM 6- K SECURITIES AND EXCHANGE COMMISSION Washington, D.Hydrocodone Bitartrate and Ibuprofen.Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/ 200 mg.
Microsoft Word - NewYork_2683824_9.DOC page 28
Microsoft Word - NewYork_2683824_9.DOC page 14
Microsoft Word - 6-K United Final.doc FORM 6- K SECURITIES AND EXCHANGE COMMISSION Washington, D.
author: liat-r
Microsoft Word - 6-K United Final.doc page 12
author: liat-r
http://www.tevapharm.com/pdf/20-F_20040315.pdf page 75
